Safety and Efficacy of Novel Clamping Device to Facilitate Sleeve Formation in Laparoscopic Sleeve Gastrectomy

Vikrom K Dhar, MD, Andrew Jung, MD, Young Kim, MD, Dennis J Hanseman, PhD, Brad Watkins, MD, Daniel Schauer, MD, Jonathan Thompson, MD, Tayyab Diwan, MD. University of Cincinnati

Background: Current techniques for gastric pouch creation with use of a Bougie in laparoscopic sleeve gastrectomy (LSG) have been shown to result in inconsistent pouch anatomy. A three point technique using a gastric clamp (GC) (Standard Clamp, Standard Bariatrics Inc., OH) for LSG is a novel approach to help surgeons maintain predetermined distances from key landmarks (incisura angularis (IA), pylorus, and gastroesophageal junction (GEJ)) during stapling. By maintaining the stomach in a flat plane, the GC facilitates resection of the entire posterior fundus while avoiding unwanted zig-zags, twists, and spirals. We sought to evaluate the safety and efficacy of the GC for use in LSG.

Methods: This is an IRB approved, retrospective review of LSG cases performed in 2016 at a center specializing in bariatric surgery. All patients underwent LSG with either use of a 40F Bougie to guide sleeve formation or use of the GC to align the staple line 1cm from the GEJ, 3cm from the IA, and 6cm from the pylorus. Patient demographics, perioperative characteristics, and post-operative complications were evaluated.

Results: 175 patients underwent LSG for management of morbid obesity either with the GC (n = 36) or with use of a Bougie (n = 139). There were no significant preoperative differences in age, preop BMI, or sex. When comparing the GC group to the Bougie group, there were no significant differences in operative time (105 minutes vs. 108 minutes; p = 0.33), overall length of stay (1.33 days vs. 1.48 days; p = 0.55), follow up nausea rate (19% vs. 22%; p = 0.82), or follow up GERD rate (14% vs. 17%; p = 0.80). There were no intraoperative complications in either group. Use of the GC resulted in a clinically significant decreased post operative complication rate (6% vs. 17%; p = 0.11) as well as a statistically significant decrease in the frequency of operations requiring more than 6 staple cartridges to complete creation of the sleeve (0% vs. 14%; p = 0.02).

Conclusions: The GC with three point technique is a safe and effective approach in LSG with favorable early outcomes compared to surgery performed with Bougie guidance. Holding the stomach in place during stapling improved resource utilization by decreasing staple cartridge waste, with the potential effect of standardizing gastric pouch formation. Future studies are required with longer term follow up to assess long term outcomes of patients undergoing LSG with the GC.